WO2012117409A1 - Broche de distribution exempte d'aiguille pour une administration sans danger d'un médicament - Google Patents

Broche de distribution exempte d'aiguille pour une administration sans danger d'un médicament Download PDF

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Publication number
WO2012117409A1
WO2012117409A1 PCT/IN2011/000125 IN2011000125W WO2012117409A1 WO 2012117409 A1 WO2012117409 A1 WO 2012117409A1 IN 2011000125 W IN2011000125 W IN 2011000125W WO 2012117409 A1 WO2012117409 A1 WO 2012117409A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
wing
shaped
free dispensing
dispensing pin
Prior art date
Application number
PCT/IN2011/000125
Other languages
English (en)
Inventor
Natrajan S. IYER
Anju Gupta Kaudanya
Original Assignee
Vhb Pharmaceuticals Private Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Vhb Pharmaceuticals Private Limited filed Critical Vhb Pharmaceuticals Private Limited
Priority to PCT/IN2011/000125 priority Critical patent/WO2012117409A1/fr
Publication of WO2012117409A1 publication Critical patent/WO2012117409A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068—Venting means
    • A61J1/2075—Venting means for external venting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2079—Filtering means
    • A61J1/2082—Filtering means for gas filtration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/162—Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
    • A61M2005/1623—Details of air intake
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/75—General characteristics of the apparatus with filters
    • A61M2205/7536—General characteristics of the apparatus with filters allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes

Definitions

  • a needle free dispensing pin for safe drug administration A needle free dispensing pin for safe drug administration
  • This invention relates to the field of intravenous administration of drug injectables and more particularly to the field of ensuring safety to drug administrators in terms of preventing release of aerosolized drug particles in the immediate environment without affecting sterility of drug being administered.
  • US Patent 5,899,877 - It relates to a connector with barbed surfaces, a conduit with a stop valve. The valve is engaged between two containers.
  • the cited work is different from the present invention that employs a cartridge, a hydrophobic filter and wings for pressure equalization.
  • US Patent 6,085,943 - It describes a device, employing a pair of closable valves and a housing with an inner chamber. The present invention has none of the features of the cited, prior work.
  • US Patent 4,768,568 It provides a septum-sealed medicament chamber, divided into a vented, variable volume, chamber and a vented, sealed, variable volume chamber. A hydrophobic filter is fitted on vented control chamber.
  • the present work has none of the features of the cited work except a hydrophobic filter.
  • WO 2007/079048 This prior work describes a vial adapter, comprised of a port each for vent and medicament. It employs, in different embodiments thereof, hydrophobic and anti-bacterial filters in vent port to regulate flow of fluid, liquid and air-borne agents. The prior work is different from the present invention, which employs the filter in and around medicament port.
  • An object of the present invention is to provide a cost effective dispensing pin that balances air pressure during reconstitution or withdrawal of injectable fluids, while maintaining sterile conditions.
  • Another object of the present invention is to prevent contamination of the immediate environment with aerosolized drug particles that would adversely affect health of personnel administering drug.
  • Another object of the present invention is to prevent potential contamination of drug being administered due to air entering through conventional dispensing pins.
  • Another object of the present invention is to eliminate occurrence of needlestick injury to drug administrators.
  • Another object of the present invention is to rid dispensing pin of dynamic/ moving parts such as valves, springs and to provide a simple device.
  • FIG. 1 illustrates general working of the needle-free
  • FIG. 1 illustrates working of the needle free dispensing pin
  • Figure # 3 illustrates plan view of hydrophobic filter media (50) assembled and firmly held in between C-shaped wings
  • Figure # 4 illustrates an exploded view of needle- free dispensing pin (100).
  • Needle-free dispensing pin (100) is a safe and effective device for use on sealed vial and intravenous bags. It is commonly observed that reconstitution of dry, sterile or lyophilized powder generates drug aerosol molecules, which are let out along with outgoing air from vial or bag into surrounding atmosphere, thereby not only exposing physicians and healthcare practitioners administering drug to dangerous effects of drug being administered but losing also potency of the drug. It is dangerous to expose daily the health personnel to this hazard. The surrounding air that enters vial or intravenous bag during reconstitution of the drug may adversely affect sterility of the drug being administered on account of being itself contaminated with atmospheric bacteria and viruses.
  • An inventive feature of the present invention lies in the provision of a hydrophobic filter (50) in the passage of incoming air to filter out bacteria and other toxins of the surrounding air and to trap the aerosolized molecules during air pressure equalization stage.
  • a hydrophobic filter 50
  • p' represents the air pressure inside the vial which is higher than p a which represents the air pressure outside the vial. Therefore, the total air pressure difference is given by,
  • the first method that is used is so-called glove box where the administrator inserts his hands into the gloves through which the access to the syringe containing the diluents or reconstitution solvent and the vial containing the drug is gained as they are placed in an enclosed box. This procedure is tedious and time consuming.
  • the second method is use of vial adaptors having a spike for piercing the elastomeric stopper, a vent lumen with filter for providing air passage and a fluid lumen where syringe is attached to withdrawal of fluids.
  • the needle free dispensing pin is a device having a filter for maintaining sterile airflow while reconstitution and withdrawal procedures.
  • Access pores for injecting fluid into or removing fluid from a system, such as a drug vial generally involves a pierceable rubber stopper formed using elastomeric material e.g. butyl rubber, natural rubber etc are placed in the opening of the vial.
  • a metal crimped closes the sealing area of the rubber bung and the vial sitting area.
  • the closure has opening or axis port, through which stopper and vial opening may be accessed. 0.2 ⁇ or 0.45 ⁇ filter is inserted into the access port.
  • the cannula pierces the rubber stopper to make fluid connection with the interior of the vial.
  • the needle-free dispensing pin ( 100) is particularly beneficial to oncologists, administering hazardous drugs to several cancer- stricken patients a day. It is a cost effective device, meant to be used as air pressure balancer during reconstitution and withdrawal of drugs, while maintaining sterile conditions. It can be used for vials as well as intravenous bags and is easily sterilized with ethylene oxide. It is a low-cost product, freed from needle to prevent needle stick injuries.
  • the needle sticks form a source in transmission of blood-borne diseases like HIV, hepatitis-B and hepatitis-C. Thousands of healthcare professionals worldwide are infected by such diseases due to the needle stick injuries.
  • the needle- free dispensing pin (100) does not have moving part like springs, valves and levers. It is comprised of three
  • the C-shaped seal (10) ensures that the hydrophobic filter (50) does not crumble under the air pressure exerted during drug reconstitution and withdrawal procedure.
  • the second inventive feature of the present invention is the C- shaped seal (10) for uniform, peripheral support to the hydrophobic filter (50).
  • the wings (11, 12) firmly hold the filter (50) after a heat and press-fit procedure.
  • the cannula (40) is disproportionately long in relation to said V-shaped body (30) and tapers at the other open end (33) thereof.
  • the dissimilarity between functioning of a conventional pierceable rubber stopper and the needle-free dispensing pin (100) of the present invention is that the former facilitate passage of contaminated air through punctured area of the rubber stopper, whereas the latter facilitates the passage of air through firstly the hydrophobic filter (50).
  • the filter (50) is hydrophobic, sterilizable, has pore size of 0.2 micron and made of whatman filter paper.
  • the material of construction for the V-shaped body (30), integrally moulded with sharp cannula (40) and the C-shaped wings (10, 10- A) is food grade olycarbonate plastic, which is moulded in the respective moulds, heated at 250 degree Celsius temperature.
  • Procedure for assembling the needle-free pin (100) comprises: (1 ) heating C-shaped seal (10) to 50 degree Celsius;
  • the needle-free dispensing pin (100) must be sterilized with ethylene oxide before use.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne une broche de distribution exempte d'aiguille qui est un dispositif à faible coût, simple, pour l'administration d'un médicament et qui élimine les problèmes rencontrés classiquement de contamination par l'air impur ambiant et d'exposition de l'administrateur de médicament à des molécules de médicament à l'état d'aérosol. La broche de distribution emploie un filtre hydrophobe maintenu fermement et d'une manière étanche à l'air entre deux ailes d'un joint d'étanchéité en forme de C. Les autres composants de l'ensemble sont un corps conique, creux, en forme de V, et une canule à bord coupant. Le filtre est pressé contre la surface supérieure du joint d'étanchéité en forme de C par le corps en forme de V et la canule au cours de l'assemblage, permettant ainsi de former un joint anti-fuites.
PCT/IN2011/000125 2011-02-28 2011-02-28 Broche de distribution exempte d'aiguille pour une administration sans danger d'un médicament WO2012117409A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/IN2011/000125 WO2012117409A1 (fr) 2011-02-28 2011-02-28 Broche de distribution exempte d'aiguille pour une administration sans danger d'un médicament

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IN2011/000125 WO2012117409A1 (fr) 2011-02-28 2011-02-28 Broche de distribution exempte d'aiguille pour une administration sans danger d'un médicament

Publications (1)

Publication Number Publication Date
WO2012117409A1 true WO2012117409A1 (fr) 2012-09-07

Family

ID=44627183

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2011/000125 WO2012117409A1 (fr) 2011-02-28 2011-02-28 Broche de distribution exempte d'aiguille pour une administration sans danger d'un médicament

Country Status (1)

Country Link
WO (1) WO2012117409A1 (fr)

Citations (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4262671A (en) * 1979-10-31 1981-04-21 Baxter Travenol Laboratories, Inc. Airway connector
GB2103590A (en) * 1981-06-12 1983-02-23 Smith & Nephew Ass Air inlet for containers
US4747518A (en) 1986-12-02 1988-05-31 Laauwe Robert H Squeeze bottle self-closing and venting dispensing valve
US4768568A (en) 1987-07-07 1988-09-06 Survival Technology, Inc. Hazardous material vial apparatus providing expansible sealed and filter vented chambers
EP0314602A2 (fr) * 1987-10-30 1989-05-03 Issei Suzuki Dispositif à bouchon pour un récipient de fluide à transfuser
US5242411A (en) 1991-01-18 1993-09-07 Terumo Kabushiki Kaisha Piercing needle having hydrophobic filter vent
WO1999008036A1 (fr) 1997-08-07 1999-02-18 Rymed Technologies, Inc. Adaptateur de flacon a medicaments multidose
US5899877A (en) 1994-04-28 1999-05-04 Primed Halberstadt Medizintechnik Gmbh One-piece dispensing device for the contamination-free administration of medicaments (cytostatica)
US6085943A (en) 1997-06-30 2000-07-11 Speedline Technologies, Inc. Controllable liquid dispensing device
US6139534A (en) * 2000-01-24 2000-10-31 Bracco Diagnostics, Inc. Vial access adapter
WO2007079048A2 (fr) 2005-12-30 2007-07-12 Cardinal Health 303, Inc. Adaptateur de fiole medicale a canule de diametre reduit et lumiere d'event agrandie
US20070244461A1 (en) 2006-04-12 2007-10-18 Fangrow Thomas F Vial for regulating pressure
EP2036529A1 (fr) * 2006-06-19 2009-03-18 Nipro Corporation Kit de préparation d'un médicament liquide
WO2009105489A1 (fr) * 2008-02-18 2009-08-27 Icu Medical, Inc. Adaptateur de fiole

Patent Citations (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4262671A (en) * 1979-10-31 1981-04-21 Baxter Travenol Laboratories, Inc. Airway connector
GB2103590A (en) * 1981-06-12 1983-02-23 Smith & Nephew Ass Air inlet for containers
US4747518A (en) 1986-12-02 1988-05-31 Laauwe Robert H Squeeze bottle self-closing and venting dispensing valve
US4768568A (en) 1987-07-07 1988-09-06 Survival Technology, Inc. Hazardous material vial apparatus providing expansible sealed and filter vented chambers
EP0314602A2 (fr) * 1987-10-30 1989-05-03 Issei Suzuki Dispositif à bouchon pour un récipient de fluide à transfuser
US5242411A (en) 1991-01-18 1993-09-07 Terumo Kabushiki Kaisha Piercing needle having hydrophobic filter vent
US5899877A (en) 1994-04-28 1999-05-04 Primed Halberstadt Medizintechnik Gmbh One-piece dispensing device for the contamination-free administration of medicaments (cytostatica)
US6085943A (en) 1997-06-30 2000-07-11 Speedline Technologies, Inc. Controllable liquid dispensing device
WO1999008036A1 (fr) 1997-08-07 1999-02-18 Rymed Technologies, Inc. Adaptateur de flacon a medicaments multidose
US6139534A (en) * 2000-01-24 2000-10-31 Bracco Diagnostics, Inc. Vial access adapter
WO2007079048A2 (fr) 2005-12-30 2007-07-12 Cardinal Health 303, Inc. Adaptateur de fiole medicale a canule de diametre reduit et lumiere d'event agrandie
US20070244461A1 (en) 2006-04-12 2007-10-18 Fangrow Thomas F Vial for regulating pressure
EP2036529A1 (fr) * 2006-06-19 2009-03-18 Nipro Corporation Kit de préparation d'un médicament liquide
WO2009105489A1 (fr) * 2008-02-18 2009-08-27 Icu Medical, Inc. Adaptateur de fiole

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